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The Daily Biotech Pulse: Amag Spikes On Takeover Rumors, Zosano Wilts On Regulatory Setback, Pulmonx Makes Wall Street Debut

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The Daily Biotech Pulse: Amag Spikes On Takeover Rumors, Zosano Wilts On Regulatory Setback, Pulmonx Makes Wall Street Debut

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 30)

  • Acceleron Pharma Inc (NASDAQ: XLRN)
  • Annexon Inc (NASDAQ: ANNX)
  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
  • Axonics Modulation Technologies Inc (NASDAQ: AXNX)
  • Beigene Ltd (NASDAQ: BGNE)
  • BioLife Solutions Inc (NASDAQ: BLFS)
  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • Cardiff Oncology Inc (NASDAQ: CRDF)
  • CareDx Inc (NASDAQ: CDNA)
  • CTI BioPharma Corp (NASDAQ: CTIC)
  • I-Mab ADR (NASDAQ: IMAB)
  • Insulet Corporation (NASDAQ: PODD)
  • Kaleido Biosciences Inc (NASDAQ: KLDO)
  • Kura Oncology Inc (NASDAQ: KURA)
  • LifeSci Acquisition Corp (NASDAQ: LSAC) (the blank check company announced a business combination with oncology-focused Vincera Pharma)
  • Mirati Therapeutics Inc (NASDAQ: MRTX)
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
  • Myokardia Inc (NASDAQ: MYOK)
  • Novocure Ltd (NASDAQ: NVCR)
  • Pacific Biosciences of California Inc (NASDAQ: PACB)
  • PMV Pharmaceuticals Inc (NASDAQ: PMVP)
  • PPD Inc (NASDAQ: PPD)
  • Seattle Genetics, Inc. (NASDAQ: SGEN)
  • Shockwave Medical Inc (NASDAQ: SWAV)
  • Zoetis Inc (NYSE: ZTS)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 30)

  • Abeona Therapeutics Inc (NASDAQ: ABEO)
  • Alector Inc (NASDAQ: ALEC)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)
  • Neos Therapeutics Inc (NASDAQ: NEOS)
  • Oncternal Therapeutics Inc (NASDAQ: ONCT)
  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX)
  • Pandion Therapeutics Inc (NASDAQ: PAND)
  • Satsuma Pharmaceuticals Inc (NASDAQ: STSA)
  • Theravance Biopharma Inc (NASDAQ: TBPH)
  • Tricida Inc (NASDAQ: TCDA)

Stocks In Focus

Amag Reportedly Pursued By Apollo's Covis Pharma

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) shares surged higher after a Bloomberg report said Apollo Management's Covis Pharma unit is in advanced talks to buy Amag.

The stock was soaring 38.83% to $13.05 premarket Thursday.

FDA Finds Zosano Migraine Drug NDA Deficient

Zosano Pharma Corp (NASDAQ: ZSAN) said it has received a discipline review letter from the FDA in connection with the Qtrypta NDA. A DRL is used by the FDA to convey preliminary comments on deficiencies identified during the review.

The DRL described two concerns with respect to the clinical pharmacology section of the NDA, the company said. Given the receipt of the letter, the company said the anticipated FDA decision may not come through by the Oct. 20 PDUFA date

The stock was down 52.48% at 77 cents premarket.

Selecta's Investigational Gout Treatment Flunks Midstage Study

Selecta Biosciences Inc (NASDAQ: SELB) and licensing partner Swedish Orphan Biovitrum AB announced negative results for the Phase 2 COMPARE trial comparing the efficacy of SEL-212 to Horizon Therapeutics PLC's (NASDAQ: HZNP) Krystexxa, the currently approved uricase in the U.S. for the treatment of chronic refractory gout.

"SEL-212 showed a numerically higher response rate on the primary endpoint during months 3 and 6 combined, but did not meet the primary endpoint of statistical superiority, Selecta said.

The stock was down 43.95% at $1.39 premarket. 

See also: The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates

Pfizer's Investigational DMD Gene Therapy Fast Tracked

Pfizer Inc. (NYSE: PFE) announced fast track designation for its investigational gene therapy candidate, PF-06939926, which is being developed to treat Duchenne muscular dystrophy.

PF-06939926 is being evaluated to determine the safety and efficacy of this gene therapy in boys with DMD, Pfizer said.

The stock was gaining 0.71% to $36.96 in premarket trading Thursday.

Provention Bio Submits Type 1 Diabetes Drug's Clinical Module 

Provention Bio Inc (NASDAQ: PRVB) announced the submission of the clinical module of its BLA for teplizumab, codenamed PRV-031. Teplizumab is an investigational anti-CD3 monoclonal antibody that is being evaluated for the delay or prevention of clinical Type 1 diabetes in at-risk individuals.

The company said it plans to submit the final modules, including the chemistry, manufacturing and controls module, in the fourth quarter, which would mark the completion of the rolling BLA submission.

The stock was up 9.12% premarket at $14. 

G1 Therapeutics Announces CEO Transition

G1 Therapeutics Inc (NASDAQ: GTHX) said its CEO Mark Velleca will transition to the role of senior advisor and continue to serve as a member of the board effective Jan. 1.

The company also announced board member John Bailey as its next CEO.

The stock was up 2.51% premarket to $11.84. 

Enlivex Reports Positive Results From COVID-19 Study

Enlivex Therapeutics Ltd (NASDAQ: ENLV) announced positive top-line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition.

All five patients recovered completely from their respective severe/critical condition and were released from the hospital after an average of 5.5 days in severe patients and 8.5 days in critical patients following administration of Allocetra, at which time they were all COVID-19 PCR negative, the company said.

In premarket trading Thursday, the stock was rising 90.4% to $11.31.

Offerings

LogicBio Therapeutics Inc (NASDAQ: LOGC) said it intends to offer shares of its common stock in an underwritten public offering. All shares being offered are to be sold by the company.

The company plans to use the net proceeds primarily for R&D, and the balance to fund working capital, capital expenditures and other general corporate purposes.

The stock was down 26.76% at $6.65 premarket. 

Clinical Readouts

Capricor Therapeutics Inc (NASDAQ: CAPR) is scheduled to present at the World Muscle Society congress with novel data from its Phase 2 HOPE-2 clinical trial with its lead investigational product, CAP-1002, in boys with Duchenne muscular dystrophy.

IPOs

Pulmonx Corporation, a commercial-stage medtech company that provides a minimally invasive treatment for patients with severe emphysema, a form of chronic obstructive pulmonary disease, priced its upsized 10-million-share initial public offering at $19 each compared to the estimated price range of $14-$16.

The Redwood City, California-based company expects to raise gross proceeds of $190 million from the offering. The shares are expected to be listed on the Nasdaq under the ticker symbol "LUNG."

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

 

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